CBD Repair Over T-tube or Primary Repair

Comparative Study : Repair of Common Bile Duct After CBD Exploration Over T-tube or Primary Repair Without Tube

the aim is to assess the benefits and harms of T-tube drainage versus primary closure without biliary stent after exploration common bile duct stones

Study Overview

• Status: Unknown
• Conditions: CBD Exploration
• Intervention / Treatment: Device: T-tube

Detailed Description

Common Bile Duct Exploration is a surgery that involves opening the main bile duct that drains from liver and gallbladder into the first part of the small intestine (the duodenum). This is needed when a gallstone drops out of the gallbladder into the duct and partially or completely blocks up the duct. This can cause jaundice , fever and chills, severe abdominal pain due to infection / inflammation of the bile duct, gallbladder or pancreas. This most often involves admission to the hospital and urgent intervention. Most commonly, a procedure called an ERCP is used to clear out the stones from the bile duct. If gallbladder will have to be removed soon to prevent this potentially serious condition from occurring again.

During the operation the investigators remove gallbladder then a duct exploration is performed. This involves opening the duct directly and removing the stones.

Prior to Common Bile Duct Exploration surgery, patient will be asked not to eat anything after midnight prior to the surgery. patient will be given specific instructions from the surgeon or anesthesiologist about which medications he should or should not take prior to the surgery. patient should not take any blood thinning medications at least 5 days prior to your operation. This should be discussed with the surgeon at the preop visit.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Mhamed Abo Elhassan, Master; Phone Number: +201001311044; Email: doctor_200799@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patient who will undergo CBD exploration for management of CBD stone

Description

Inclusion Criteria:

• Patients who will undergo common bile duct exploration

Exclusion Criteria:

• patients who has failed ERCP for management of common bile duct exploration
• CBD diameter 2 cm or more

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CBD exploration with T-tube; repair of CBD after CBD exploration over T-tube	Device: T-tube; T shaped tube used as stent after CBD exploration
CBD exploration with primary repair; primary repair of CBD after CBD exploration	Device: T-tube; T shaped tube used as stent after CBD exploration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bile leak from common bile duct	Assessment which type of repair (with T-tube or primary repair) bile leak will occurs more	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital stay length	Assessment which type of repair (with T-tube or primary repair) patient will stay in the hospital more after CBD exploration	base line

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Wu X, Huang ZJ, Zhong JY, Ran YH, Ma ML, Zhang HW. Laparoscopic common bile duct exploration with primary closure is safe for management of choledocholithiasis in elderly patients. Hepatobiliary Pancreat Dis Int. 2019 Dec;18(6):557-561. doi: 10.1016/j.hbpd.2019.07.005. Epub 2019 Jul 25.
• Guan H, Jiang G, Mao X. Primary duct closure combined with transcystic drainage versus T-tube drainage after laparoscopic choledochotomy. ANZ J Surg. 2019 Jul;89(7-8):885-888. doi: 10.1111/ans.15163. Epub 2019 May 8.
• Jiang C, Zhao X, Cheng S. T-Tube Use After Laparoscopic Common Bile Duct Exploration. JSLS. 2019 Jan-Mar;23(1):e2018.00077. doi: 10.4293/JSLS.2018.00077.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 25, 2019
• Primary Completion (ANTICIPATED): March 30, 2022
• Study Completion (ANTICIPATED): July 30, 2022

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (ACTUAL): September 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CBD exploration

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No